June 2023 • PharmaTimes Magazine • 24-25

// MEDICINES //


Euro vision!

The EU Commission’s proposals to revise pharmaceutical legislation is a step forward but there is more work to do

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The European Medicines Agency (EMA) has recently released proposed changes to the pharmaceutical regulations in the European Union (EU), the first major review of these requirements since 2004.

The reform aims to adapt the legislation to the needs of the 21st century and achieve several key objectives that will benefit both the industry and the public. While the proposed changes will bring some positive developments, there are some important considerations that have not been fully addressed.

Creating a single market to deliver safe, effective and affordable medicines for all patients in the EU is a unique challenge.

The primary objectives of the proposed reforms include creating a single market for medicines and ensuring timely, equitable access to safe, effective and affordable medicines for all patients in the EU.

The reforms also aim to foster an innovation-friendly framework for research, development and production of medicines within Europe. Additionally, the administrative burden will be significantly reduced, resulting in faster authorisation times for medicines and enhancing the availability of medicines for patients across the EU.


‘The primary objectives of the proposed reforms include creating a single market for medicines and ensuring timely, equitable access’


Addressing the need for action on antimicrobial resistance (AMR) and making medicines more environmentally sustainable are also key priorities.

There are also two legislative proposals – a new Directive and a new Regulation. The Directive includes all the requirements for authorisation, monitoring, labelling, regulatory protection and other procedures for all medicines authorized at both EU and national levels.

The regulation sets specific rules for medicines authorised at the EU level, particularly the most innovative ones. It also governs the EMA and sets rules for coordinated management of critical shortages and security of supply of critical medicines.

Chain reaction

One of the key changes introduced by the reform is the shift from a ‘one-size-fits-all’ system of incentives for pharmaceutical companies to a modulated system that rewards companies for fulfilling important public health objectives.

These include giving access to medicines in all member states, developing medicines that address unmet medical needs, including the medical needs of patients with rare diseases and of children, conducting comparative clinical trials and the development of new antibiotics.

There are, however, several gaps in the proposed reforms around the measures to create robust supply chains to avoid shortages of drugs.

  • Visibility and transparency; The reform does not explicitly address the need for increased visibility and transparency throughout the pharmaceutical supply chain. Lack of visibility about the movement of drugs from manufacturers to patients can contribute to shortages. Implementing mechanisms to track and trace medications at each stage of the supply chain could help identify bottlenecks and mitigate potential disruption
  • Inventory Management: The lack of specific guidelines or requirements for inventory management is another missed opportunity. Encouraging the adoption of best practices in inventory management, including forecasting demand, monitoring stock levels and implementing contingency plans, would help prevent shortages
  • Over-reliance on a single supplier: The reforms do not sufficiently address the issue of over-reliance on a single supplier or manufacturing site for essential drugs. Diversifying the sourcing of critical medications and encouraging the establishment of redundant manufacturing capabilities could enhance supply chain resilience and reduce its vulnerability to disruption
  • Collaboration: While the proposed reforms mention the importance of collaboration between regulatory authorities and industry stakeholders, there is limited emphasis on fostering effective communication and collaboration within the supply chain itself. Strengthening this collaboration could enable a more proactive approach to dealing with potential supply chain issues
  • Risk assessments: Conducting comprehensive risk assessments, including identifying vulnerabilities, assessing potential disruptions and implementing appropriate risk mitigation measures, is essential to prevent drug shortages. No detailed guidelines, however, have been provided to support pharmaceutical companies develop this work. The same problem applies to contingency planning where the reforms have failed to require the development of standardised contingency plans.

As an antidote to some of these challenges, data analytics tools can now monitor supply chain performance, analyse data on inventory levels and provide early warning signs of potential disruptions. Greater use of these tools would help provide additional assurance to regulators.

Small to medium hurdles

The reforms relating to supply chains will pose specific challenges for small to medium-sized enterprises (SMEs). Smaller companies could face difficulties in meeting new traceability or serialisation requirements, implementing sophisticated inventory management systems, or establishing robust supplier relationships.
These challenges could disrupt their supply chain operations and impact their ability to ensure consistent and timely product availability.

While SMEs will benefit from the reductions in bureaucracy, they will also face some new hurdles too. Implementing regulatory changes and meeting new requirements can impose significant financial burdens on them.

There will be compliance costs, such as obtaining certifications, conducting additional testing, or investing in new infrastructure. Complying with new regulations, such as reporting requirements or quality control measures, will require additional resources or external support and disproportionately affect smaller companies with limited resources and budgets.

In particular, the reforms do not adequately address intellectual property (IP) protection concerns for SMEs. Intellectual property rights play a crucial role in incentivising innovation and protecting the investments made by pharmaceutical companies.

Furthermore, SMEs will face challenges in protecting their IP due to limited resources or the potential for legal disputes with larger competitors, which can undermine their ability to thrive and grow.

The proposal also raises the bar for SMEs by requiring them to provide a paediatric investigation plan, even if their drug is intended to treat a disease in adults but may also be used to treat a different disease in children. This requirement could pose a significant burden for SMEs that lack the resources of larger companies.

To fully capitalise on the potential benefits of the proposed legislation, SMEs in the pharmaceutical industry may need to seek out external support and resources to meet the new requirements and compete with larger companies.

Sustaining sustainability

The proposal requires an environmental risk assessment as part of the application and for pharma companies to conduct post-market environmental monitoring, but the lack of requirements related to sustainability and environmental impact in the proposed reforms is another significant gap.

Pharmaceutical production contributes to carbon dioxide emissions, energy consumption and waste generation. Promoting the use of renewable and recyclable packaging materials, such as bio-based plastics or sustainable alternatives, could significantly reduce the industry’s plastic waste and carbon footprint.

Equally, encouraging or mandating the adoption of cleaner technologies, energy-efficient practices and renewable energy sources would have helped mitigate the industry’s environmental impact.

The failure to require environmental reporting mechanisms misses the chance to enhance transparency and accountability, allowing stakeholders to monitor and evaluate the industry’s progress in reducing its environmental impact.

Overall, the proposed reforms are a significant step towards creating a single market for medicines. They will make progress towards ensuring timely and equitable access to safe, effective and affordable medicines for all patients in the EU, while also addressing AMR challenges.

While there is more to do, they represent positive steps towards making medicines more environmentally sustainable. The shift from a ‘one-size-fits-all’ system of incentives is also a positive change. In certain areas, however, regulators have missed an opportunity and future reboots are inevitable.


Rowan Nidd and Mayur Patel cover regulatory affairs and life sciences at PA Consulting.
Go to paconsulting.com